UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT
TO RULE 13a-16 OR 15d-16 UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For the month of: February, 2008
Commission File Number: 000-50393
NEUROCHEM INC.
275 Armand-Frappier Boulevard
Laval, Québec
H7V 4A7
Indicate by check mark whether the registrant files or will file annual reports under cover of Form
20-F or Form 40 F.
Form 20-F
o
Form 40-F
þ
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(1):
Yes
o
No
þ
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by
Regulation S-T Rule 101(b)(7):
Yes
o
No
þ
Indicate by check mark whether the registrant by furnishing the information contained in this Form
is also thereby furnishing the information to the Commission pursuant to Rule 12g-3 under the
Securities Exchange Act of 1934.
Yes
o
No
þ
If Yes is marked, indicate below the file number assigned to the registrant in connection with
Rule 12g3-2(b):
SIGNATURES:
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
|
|
|
|
|
|
NEUROCHEM INC.
|
|
February 21, 2008
|
|
|
|
|
By:
|
/s/ David Skinner
|
|
|
|
David Skinner, Vice-President
|
|
|
|
General Counsel and Corporate Secretary
|
|
|
The Material Change Report of Neurochem Inc. (the Registrant) dated February 21, 2008 is
submitted with this Form 6-K and is hereby incorporated by reference into, and as an exhibit to,
the Registrants registration statement on Form F-10 (SEC Reg. No. 333-140039).
|
|
|
|
|
Neurochem Inc
.
275 Armand-Frappier Blvd.
Laval, Quebec, Canada H7V 4A7
|
|
|
|
|
|
|
|
For further information, please contact:
|
|
|
Lise Hébert, Ph.D.
|
|
Tel: 1-450-680-4572
|
Vice President, Corporate Communications
|
|
lhebert@neurochem.com
|
NEUROCHEM REPORTS RESULTS
FOR FOURTH QUARTER AND FISCAL YEAR 2007
AND IMPORTANT ADVANCES ON CORPORATE OBJECTIVES
Neurochem will host a conference call Thursday, February 21, 2008, at 8:30 A.M. ET.
LAVAL, CANADA, February 20, 2008
Neurochem Inc. (NASDAQ: NRMX; TSX: NRM) reports results for the
fourth quarter and fiscal year ended December 31, 2007, and announces important advances regarding
the Companys pharmaceutical and nutraceutical activities. The Company reports, for the fourth
quarter, a net loss of $16,097,000 ($0.33 per share), compared to $17,011,000 ($0.44 per share) for
the corresponding period in the previous year. For the year ended December 31, 2007, the net loss
amounted to $81,486,000 ($1.85 per share), compared to $66,469,000 ($1.72 per share) for the same
period last year. The
net loss
for the year ended December 31, 2007, includes a non-recurring
charge in the second quarter of fiscal 2007 under Canadian GAAP of $10,430,000 relating to the $40
million 5% senior subordinated convertible notes, which were fully converted into common shares
during the second quarter of 2007. In total, accretion expense amounted to $15,751,000 for the year
ended December 31, 2007. As at December 31, 2007, the Company had available cash, cash equivalents
and marketable securities of $58,672,000, compared to $48,758,000 at December 31, 2006. All figures
are in U.S. dollars, unless otherwise specified.
Furthermore, the Company is pleased to announce the following important developments:
|
|
|
The regulatory submission for the initiation of the Phase II clinical trial with the
investigational product candidate NC-503 in patients with Type II Diabetes as well as
certain features of Metabolic Syndrome was accepted by the Therapeutic Products
Directorate of Health Canada. As a result, the first patient is expected to be enrolled
shortly. The key objectives of the study are to investigate the safety and
proof-of-concept efficacy of NC-503 on glycemic measures.
|
|
|
|
|
In order to more accurately reflect the Companys expanded business strategy and core
programs that encompass both therapeutics and branded nutraceutical products, and
following the approval by Neurochems Board of Directors, the
|
1
|
|
|
name-change from Neurochem to BELLUS HEALTH, pending shareholder approval at the next
annual meeting.
|
|
|
|
Approval by Neurochems Board of Directors for the creation of subsidiaries for the
purposes of carrying on the Companys nutraceutical business, and as part of these new
developments, the nutraceutical business will be named OVOS NATURAL HEALTH.
|
|
|
|
|
An amendment under the Equity Line of Credit Facility, extending the term to February
2010. The minimum draw-down obligation by the Company has been reduced to $15,000,000 over
the term. The maximum amount of each monthly draw-down is limited to the lower of
$6,000,000 or 12.5% of the volume-weighted price calculation of the common shares at the
time of draw-down. The common shares will be issued at a discount of 4.0% to market price
if the volume-weighted average price (VWAP) per share is $6 or higher and 7% if the VWAP
per share is lower than $6 at the time of draw-down.
|
Neurochem is making significant progress in the implementation of the strategy that aims to make
homotaurine available to consumers. Our drive towards the commercialization of this brand under the
leadership of Mr. Gary Schmid as CEO of our nutraceutical business is geared towards potentially
selling homotaurine via the Internet as early as the second quarter of 2008 and made available at
retail in Canada during the third quarter of 2008, said Dr. Francesco Bellini, Chairman, President
and CEO of Neurochem. With respect to our pharmaceutical activities, we are continuing to
accelerate the development of our product candidates in the field of Diabetes and Alzheimers
disease and closely working with the regulatory agencies in Europe and the United States to
hopefully be in a position to make KIACTA available to patients suffering from Amyloid A (AA)
amyloidosis. The launch of a Phase II study for NC-503 as a treatment for Type II Diabetes as well
as certain features of Metabolic Syndrome is very encouraging. As a natural extension of our work
in the field of AA amyloidosis, we start with a solid base of knowledge and research already
completed, Dr. Bellini concluded.
Phase II Study for Type II Diabetes as well as certain features of Metabolic Syndrome Underway
The Phase II clinical trial is a 26 weeks multi-center, randomized, double blind,
placebo-controlled and parallel-designed study that will involve approximately 200 patients with
Type II Diabetes as well as certain features of Metabolic Syndrome in about 15 clinical sites in
Canada.
Conference Call
Neurochem will host a conference call Thursday, February 21, 2008, at 8:30 A.M. Eastern Time. The
telephone numbers to access the conference call are 1-416-644-3416 or 1-800-732-9303. A replay of
the call will be available until Thursday, February 28, 2008. The telephone numbers to access the
replay of the call are 1-416-640-1917 or 1-877-289-8525, for which the passcode is 21263770#.
Please dial-in approximately 15 minutes before the teleconference is scheduled to begin.
2
Consolidated Financial Results Highlights
The following discussion and analysis should be read in conjunction with the Companys audited
consolidated financial statements for the year ended December 31, 2007, which have been prepared in
accordance with Canadian generally accepted accounting principles (GAAP).
Results of operations
As previously reported, effective July 1, 2007, the Company adopted the US dollar as its functional
and reporting currency, as a significant portion of its revenue, expenses, assets, liabilities and
financing are denominated in US dollars. All currency figures reported in this document, including
comparative figures, are reported in US dollars, unless otherwise specified.
For the three-month period ended December 31, 2007, the
net loss
amounted to $16,097,000 ($0.33 per
share), compared to $17,011,000 ($0.44 per share) for the corresponding period in the previous
year. For the year ended December 31, 2007, the net loss amounted to $81,486,000 ($1.85 per share),
compared to $66,469,000 ($1.72 per share) for the same period the previous year.
The
net loss
for the year ended December 31, 2007, includes a non-recurring charge in the second
quarter of fiscal 2007 under Canadian GAAP of $10,430,000 relating to the $40 million 5% senior
subordinated convertible notes, which were fully converted into common shares during the second
quarter of 2007. In total, accretion expense amounted to $15,751,000 for the year ended December
31, 2007.
Revenue from collaboration agreement
amounted to $206,000 for the current quarter ($1,119,000 for
the year), compared to $497,000 for the same period in the previous year ($2,106,000 for the year).
This revenue is earned under the agreement with Centocor, Inc. (Centocor) in respect of eprodisate
(KIACTA), an oral investigational product candidate for the treatment of Amyloid A (AA)
amyloidosis. Revenue recognized is in respect of the non-refundable upfront payment received from
Centocor, which is being amortized over the estimated period through to the anticipated regulatory
approval date of the investigational product candidate. The estimated period is subject to change
based on additional information that the Company may receive periodically. The other portion of the
upfront payment received from Centocor ($6,000,000) has been classified as deferred revenue and is
not being amortized as earned revenue given that it is potentially refundable. In the event that
the Company receives an approval letter issued by the US Food and Drug Administration (FDA), the
amount would no longer be refundable and would be amortized as earned revenue.
In December 2007, the Company received an acknowledgement from the FDA that Neurochems response to
the approvable letter received in July 2007 for the New Drug Application (NDA) for eprodisate
(KIACTA
TM
) for the treatment of AA amyloidosis is a complete, Class 2 response. The
PDUFA (Prescription Drug User Fee Act) goal date by which the FDA is expected to render a decision
is April 2, 2008. In the second approvable letter (July 2007), the FDA indicated that an additional
efficacy trial will be necessary before the FDA could approve the investigational product
candidate. The
3
approvable letter also states that additional submissions, filed by Neurochem as part of its
response to this approvable letter, may address issues raised in this letter. The FDA has indicated
that additional submissions could persuade the agency to eliminate the requirement for an
additional trial. The FDA also asked for additional information, including further pharmacokinetic
studies, and again acknowledged that a QT clinical study should be submitted as part of a Phase IV
(post-approval) commitment.
Neurochem has also submitted for marketing approval eprodisate (KIACTA) for the treatment of AA
amyloidosis in the European Union and Switzerland. In December 2007, the Committee for Medicinal
Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA),
issued a negative opinion recommending refusal of the marketing authorization application (MAA) for
eprodisate (KIACTA
TM
) for the treatment of AA amyloidosis in the European Union and
concluded that another study would be needed to demonstrate eprodisates (KIACTA
TM
)
effectiveness. The Company requested a re-examination of the opinion by CHMP. As provided by the
European regulations, the Company requested that the CHMP consult a Scientific Advisory Group in
connection with the re-examination. The MAA is being reviewed under the EMEAs centralized
procedure. An authorization from the EMEA would apply to all 27 European Union member states, as
well as Norway and Iceland.
The decrease in revenue from collaboration agreement for the current periods compared to the same
periods in the previous year is mainly attributable to a change in the estimated period over which
the non-refundable upfront payment received from Centocor in respect of eprodisate (KIACTA) is
being amortized.
Reimbursable costs revenue
amounted to $64,000 for the current quarter ($396,000 for the year),
compared to $178,000 for the same period in the previous year ($712,000 for the year) and consists
of costs reimbursable by Centocor in respect of eprodisate (KIACTA)-related activities. The
Company earns no margin on these reimbursable costs.
Research and development expenses
, before research tax credits and grants, amounted to $12,199,000
for the current quarter ($55,732,000 for the year), compared to $14,142,000 for the same period in
the previous year ($51,688,000 for the year). The decrease in the current quarter compared to the
same period the previous year is mainly attributable to a reduction in expenses incurred in
relation to the development of tramiprosate (ALZHEMED), primarily in respect of the North American
Phase III clinical trial. Also, during the second quarter of 2007, the workforce was reduced due to
delay encountered in the product candidate development programs. The increase in the current year
compared to the same period the previous year is due to expenses incurred in relation to the
development of tramiprosate (ALZHEMED), primarily in respect of the Phase III clinical trial in
Europe and the North American open-label extension of the Phase III study, as well as the conduct
of a QT cardiac status Phase I study. For the year ended December 31, 2007, research and
development expenses also included costs incurred to support the North American Phase III clinical
trial for tramiprosate (ALZHEMED), the open-label extension of the eprodisate (KIACTA) Phase
II/III study, as well as ongoing drug discovery programs.
4
In November 2007, the Company announced important initiatives following key events that took place
over the past year. The Company announced the termination of the tramiprosate (ALZHEMED;
homotaurine) pharmaceutical drug development program, including the early termination of its
European Phase III clinical trial, and the advancement of its next generation prodrug of
tramiprosate (ALZHEMED) into preclinical development for the treatment of Alzheimers disease
(AD). Also, the Company announced its decision to take steps to commercialize homotaurine as a
branded nutraceutical, potentially starting as early as 2008.
Research tax credits and grants
amounted to $727,000 this quarter ($2,161,000 for the year),
compared to $607,000 for the corresponding period in the previous year ($1,899,000 for the year).
Research tax credits represent refundable tax credits earned under the Quebec Scientific Research
and Experimental Development Program for expenditures incurred in Quebec. The increase is due to
higher eligible expenditures in the current periods and the realization of tax credits from prior
years that met the criteria for recognition in the current year.
Other research and development charges
amounted to nil for the current quarter and year, compared
to $1,127,000 for the quarter and year ended December 31, 2006. In 2006, the Quebec taxation
authorities confirmed their position in the application of the tax credit program that denied tax
credits on research and development taxable benefits relating to stock options for 2005 and prior
years. Accordingly, management determined at that time that the criteria for recognition of these
credits were no longer met and recorded a provision for these research tax credits.
General and administrative expenses
totaled $1,397,000 for the current quarter ($10,581,000 for the
year), compared to $2,819,000 for the same quarter in the previous year ($11,522,000 for the year).
These costs are incurred to support the overall activities of the Company. The decrease is mainly
attributable to a reduction in management bonuses, and in performance-based fees due to Picchio
International Inc.
Arbitral award
amounted to nil for the current quarter and year compared to nil for the quarter
ended December 31, 2006 and $1,835,000 for the year ended December 31, 2006. This expense related
to the dispute with Immtech Pharmaceuticals, Inc. (formerly known as Immtech International, Inc.
(Immtech), which came to a conclusion in January 2007 when Immtech, the University of North
Carolina at Chapel Hill (UNC), and Georgia State University Research Foundation, Inc. filed with
the Federal District Court for the Southern District of New York, U.S.A. a Notice of Voluntary
Dismissal. The plaintiffs voluntarily dismissed their complaint against Neurochem in the Federal
District Court without any payment, license, business agreement, concession or compromise by
Neurochem.
Reimbursable costs
amounted to $64,000 for the current quarter ($396,000 for the year), compared to
$178,000 for the same period in the previous year ($712,000 for the year), and consist of costs
incurred on behalf of Centocor in respect of eprodisate (KIACTA)-related activities and
reimbursable by Centocor.
5
Stock-based compensation
amounted to $1,421,000 for the current quarter ($4,275,000 for the year),
compared to $924,000 for the corresponding quarter in the previous year ($3,569,000 for the year).
This expense relates to stock options and stock-based incentives, whereby compensation cost in
relation to stock options is measured at fair value at the date of grant and is expensed over the
awards vesting period. The increase is due to new stock options granted during the past year.
Depreciation, amortization and patent cost write-off
amounted to $611,000 for the current quarter
($1,698,000 for the year), compared to $386,000 for the corresponding quarter in the previous year
($1,556,000 for the year). The increase is attributable to patent cost of $239,000 written off
during the year, for which no future benefit was expected to be realized.
Interest income
amounted to $756,000 for the current quarter ($3,341,000 for the year), compared to
$574,000 for the same quarter in the previous year ($2,077,000 for the year). The increase is
mainly attributable to higher average cash balances during the current periods, compared to the
same periods in the previous year.
Accretion expense
amounted to $1,183,000 for the current quarter ($15,751,000 for the year),
compared to $550,000 for the same quarter in the previous year ($550,000 for the year). Accretion
expense represents the imputed interest under GAAP on the $42,085,000 aggregate principal amount of
6% convertible senior notes issued in November 2006, as well as on the $40,000,000 6% senior
convertible notes (Senior Notes) and $40,000,000 5% senior subordinated convertible notes (Junior
Notes) issued in May 2007. The Company accretes the carrying values of the convertible notes to
their face value through a charge to earnings over their expected lives of 60 months, 54 months and
1 month, respectively. Of the total accretion expense recorded in the year ended December 31, 2007,
$10,430,000 relates to accretion expense on the Junior Notes, which were fully converted during the
second quarter of 2007. Refer to the Liquidity and Capital Resources section for more details on
the convertible notes.
Change in fair value of embedded derivatives
amounted to a gain of $28,000 for the current quarter
(loss of $870,000 for the year) and represents the variation in the fair value of the embedded
derivatives included in the aggregate $80,000,000 Senior and Junior Notes issued in May 2007.
Change in fair value of third party asset-backed commercial paper
amounted to a loss of $1,184,000
for the quarter and year ended December 31, 2007 and represents a provision recorded on the
valuation of asset-backed commercial paper held by the Company. Refer to Liquidity and Capital
Resources section for more details.
Foreign exchange loss
amounted to $54,000 for the current quarter (gain of $1,130,000 for the
year), compared to a gain of $245,000 for the same quarter in the previous year (loss of $280,000
for the year). Foreign exchange gains or losses arise on the movement in foreign exchange rates in
relation to the Companys net monetary assets denominated in currencies other than US dollars,
which is its functional and reporting currency, and consists primarily of monetary assets and
liabilities denominated in Canadian dollars. Foreign exchange gains recognized for the year ended
December 31, 2007, are mainly
6
attributable to the strengthening of the Canadian dollar compared to the US dollar during the
period.
Other income
amounted to $287,000 for the current quarter ($1,274,000 for the year), compared to
$282,000 for the same quarter in the previous year ($1,348,000 for the year). Other income consists
of non-operating revenue, primarily sub-lease revenue. The 2006 income includes an amount of
$293,000 in respect of the recovery of prior years property taxes.
Share of loss in a company subject to significant influence
amounted to nil for the current quarter
($327,000 for the year), compared to $489,000 for the corresponding quarter in the previous year
($2,440,000 for the year).
Non-controlling interest
amounted to nil for the current quarter
($109,000 for the year), compared to $162,000 for the corresponding quarter in the previous year
($801,000 for the year). These items result from the consolidation of the Companys interest in a
holding company (Innodia Holding) that owns shares of Innodia Inc., for which Neurochem is the
primary beneficiary. The share of loss recorded in the current year has reduced the Companys
long-term investment in Innodia Holding to a nominal value. Innodia Inc. is a private,
development-stage company engaged in developing novel drugs for the treatment of Type II diabetes
and underlying diseases.
Liquidity and capital resources
As at December 31, 2007, the Company had available cash, cash equivalents and marketable securities
of $58,672,000, compared to $48,758,000 at December 31, 2006. The increase is primarily due to
proceeds received from the issue of convertible notes in May 2007 and is partially offset by funds
used in operating activities.
On May 2, 2007, the Company issued $80,000,000 aggregate principal amount of convertible notes,
consisting of $40,000,000 6% senior convertible notes due in 2027 and $40,000,000 5% senior
subordinated convertible notes due in 2012. The 6% senior convertible notes have an initial
conversion price equal to the lesser of $12.68 or the 5-day weighted average trading price of the
common shares preceding any conversion, subject to adjustments in certain circumstances. The
Company will pay interest on the 6% senior convertible notes until maturity on May 2, 2027, subject
to earlier repurchase, redemption or conversion. The 5% senior subordinated convertible notes were
subject to mandatory conversion into common shares under certain circumstances. In connection with
this transaction, the Company issued warrants to purchase an aggregate of 2,250,645 common shares
until May 2, 2012, at an initial purchase price of $12.68 per share, subject to adjustments in
certain circumstances. . During the year ended December 31, 2007, $35,500,000 of the 6% senior
convertible notes were converted into 5,619,321 common shares and the totality of the 5% senior
subordinated convertible notes were converted into 4,444,449 common shares. Net proceeds from the
offering were $74,279,000 and, as of December 31, 2007, $34,274,000 has yet to be spent. As at
December 31, 2007, the use of proceeds has conformed in all material respects with the expectations
set forth in the prospectus filed publicly.
7
In August 2006, the Company entered into a securities purchase agreement in respect of an equity
line of credit facility (ELOC) with Cityplatz Limited (Cityplatz), that provides the Company up to
$60,000,000 of funds in return for the issuance of common shares at a discount of 3.0% to market
price at the time of draw downs over term, less a placement fee equal to 2.4% of gross proceeds
payable to the placement agent, Rodman & Renshaw, LLC. The ELOC established by the securities
purchase agreement will terminate on February 9, 2009. The ELOC shall also terminate if (i) the
Companys common shares are de-listed from NASDAQ unless the common shares are listed at such time
on another trading market specified in the agreement and such de-listing is in connection with a
subsequent listing on another trading market specified in the agreement, (ii) the Company is
subject to a change of control transaction or (iii) the Company suffers a material adverse effect
which cannot be cured prior to the next drawdown notice. The Company may terminate the securities
purchase agreement (i) if Cityplatz fails to fund a properly notified drawdown within five trading
days of the end of the applicable settlement period or (ii) after it has drawn down at least
$25,000,000 under the ELOC. Either party may also terminate the securities purchase agreement if
the volume-weighted average price of the Companys common shares is below $5 per share for more
than 30 consecutive trading days. Given that the current price per share has been below the minimum
price as per the agreement, the agreement may be terminated at any time. As at December 31, 2007,
the Company had not drawn any funds under the ELOC. See subsequent event note for terms of
amendment.
Restricted Cash presented on the Consolidated Balance Sheet is composed of short-term investments
pledged to a bank as collateral for two letters of credit; the first in the amount of $6,000,000
was issued in connection with the potentially refundable upfront payment received under the
collaboration agreement with Centocor and the second in the amount of CDN$640,000 was granted in
favour of a landlord in relation to the lease of a building. As at December 31, 2007, restricted
cash is composed of third-party Asset-Backed Commercial Paper (ABCP). These investments were due to
mature during the second quarter of 2007 but, as a result of a disruption in the credit markets,
particularly in the ABCP market, they did not settle on maturity and currently remain outstanding.
At the time these investments were acquired, the ABCP were rated R1-high by Dominion Bond Rating
Service, which is the highest credit rating for this type of investment. The ABCP are currently
subject to a restructuring proposal under a standstill agreement which is expected to result in the
conversion of the ABCP into longer-term financial instruments with maturities corresponding to the
underlying assets. A Pan-Canadian Investors Committee (the Committee) was established to oversee
the orderly restructuring of these instruments during this standstill period. A restructuring plan
was announced by the Committee on December 23, 2007, and is anticipated to be completed by the end
of March, 2008. During the quarter ended December 31, 2007, the Company recorded a provision for
losses in the amount of $1,184,000 in respect of ABCP, reflecting the Companys estimated reduction
in the fair value of these investments as at December 31, 2007. The Company estimated the fair
value of the ABCP using a probability weighted discounted cash flow approach, based on its best
estimates of the time period over which the assets are going to generate cash flows ranging from 7
to 30 years based on the proposed restructuring, the coupon interest rate, the discount rate to
apply to the net cash flows anticipated to be received commensurate with highly rated notes and
other qualitative factors. This estimate of the fair value of the ABCP is not supported by
8
observable market prices or rates, therefore is subject to uncertainty, including, but not limited
to, the outcome of the restructuring plan being considered, the estimated amounts to be recovered,
the yield of the substitute financial instruments and the timing of future cash flows. The
resolution of these uncertainties could be such that the ultimate fair value of these investments
may vary from the Companys current best estimate. Changes in the near term could require changes
in the recognized amount of these assets. The Company does not expect there will be a material
adverse impact on its business as a result of the Third Party ABCP liquidity issue. During the
third and fourth quarter of 2007, both letters of credit were renewed upon their respective annual
expiry, with the ABCP issued as collateral.
As at December 31, 2007, the Companys workforce comprised 170 employees.
As at January 31, 2008, the Company had 48,848,095 common shares outstanding, 220,000 common shares
issuable to the Chief Executive Officer upon the achievement of specified performance targets,
2,815,233 options granted under the stock option plan, 2,884,471 shares currently issuable under
the convertible notes, and 2,250,645 warrants outstanding, for a total of 57,018,444 common shares,
on a fully diluted basis.
The Company believes that its available cash and short-term investments, expected interest income,
potential revenues from commercialization of nutraceutical products, potential funding from
partnerships, research collaborations and licensing agreements, potential proceeds from the equity
line of credit facility, potential revenue from commercialization of nutraceutical products,
research tax credits, grants, and access to capital markets should be sufficient to finance the
Companys operations and capital needs during the ensuing fiscal year. However, in light of the
uncertainties associated with the regulatory approval process, clinical trial results,
commercialization of nutraceutical products, and the Companys ability to secure additional
licensing, partnership and/or other agreements, further financing may be required to support the
Companys operations in the future.
Change in functional and reporting currency
Effective July 1, 2007, the Company adopted the US dollar as its functional and reporting currency,
as a significant portion of its revenues, expenses, assets, liabilities and financing are
denominated in US dollars. Prior to that date, the Companys operations were measured in Canadian
dollars and the consolidated financial statements were expressed in Canadian dollars. The Company
followed the recommendations of the Emerging Issues Committee (EIC) of the Canadian Institute of
Chartered Accountants (CICA), set out in EIC-130, Translation method when the reporting currency
differs from the measurement currency or there is a change in the reporting currency. In
accordance with EIC-130, assets and liabilities as of June 30, 2007 were translated in US dollars
using the exchange rate in effect on that date; revenues, expenses and cash flows were translated
at the average rate in effect during the six-month period ended June 30, 2007, and equity
transactions were translated at historical rates. For comparative purposes, historical financial
statements have been restated into US dollars using the current rate method. Under this method,
assets and liabilities are translated at the closing rate in effect at the end of these periods,
revenues, expenses and cash flows are translated
9
at the average rates in effect during these periods and equity transactions are translated at
historical rates. Any exchange differences resulting from the translation are included in
accumulated other comprehensive income presented in shareholders equity.
Subsequent event
On February 20, 2008, the Board of Directors approved the following transactions:
(a) The issuance of 2,445,000 options to purchase common shares to be issued under the stock option
plan of the Company. The option price per share will be determined based on the weighted average
trading price of common shares for the five days preceding the date of grant during which the
common shares were traded on the Toronto Stock Exchange.
(b) The Company renewed the management services agreement entered into with Picchio International
Inc. to November 30, 2008.
(c) The Company entered into an amendment with respect to the ELOC facility. The term of the ELOC
facility has been extended to February 2010. The minimum draw-down obligation by the Company has
been reduced to $15,000,000 over the term. The maximum amount of each monthly draw-down is limited
to the lower of $6,000,000 or 12.5% of the volume-weighted price calculation of the common shares
at the time of draw-down. The common shares will be issued at a discount of 4.0% to market price if
the volume-weighted average price (VWAP) per share is $6 or higher, and 7% if the VWAP per share is
lower than $6 at the time of draw-down
10
Neurochem Inc.
Consolidated Financial Information
1
(in thousands of US dollars, except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-month period ended
|
|
|
Year ended
|
|
|
|
December 31
|
|
|
December 31
|
|
Consolidated Statements of Operations
|
|
2007
|
|
|
2006
|
|
|
2007
|
|
|
2006
|
|
|
|
(unaudited)
|
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration agreement
|
|
$
|
206
|
|
|
$
|
497
|
|
|
$
|
1,119
|
|
|
$
|
2,106
|
|
Reimbursable costs
|
|
|
64
|
|
|
|
178
|
|
|
|
396
|
|
|
|
712
|
|
|
|
|
|
270
|
|
|
|
675
|
|
|
|
1,515
|
|
|
|
2,818
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
|
12,199
|
|
|
|
14,142
|
|
|
|
55,732
|
|
|
|
51,688
|
|
Research tax credits and grants
|
|
|
(727
|
)
|
|
|
(607
|
)
|
|
|
(2,161
|
)
|
|
|
(1,899
|
)
|
Other research and development charges
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,127
|
|
|
|
|
|
11,472
|
|
|
|
13,535
|
|
|
|
53,571
|
|
|
|
50,916
|
|
General and administrative
|
|
|
1,397
|
|
|
|
2,819
|
|
|
|
10,581
|
|
|
|
11,522
|
|
Arbitral award
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,835
|
|
Reimbursable costs
|
|
|
64
|
|
|
|
178
|
|
|
|
396
|
|
|
|
712
|
|
Stock-based compensation
|
|
|
1,421
|
|
|
|
924
|
|
|
|
4,275
|
|
|
|
3,569
|
|
Depreciation, amortization and patent
cost write-off
|
|
|
611
|
|
|
|
386
|
|
|
|
1,698
|
|
|
|
1,556
|
|
|
|
|
|
14,965
|
|
|
|
17,842
|
|
|
|
70,521
|
|
|
|
70,110
|
|
|
Loss before undernoted items
|
|
|
(14,695
|
)
|
|
|
(17,167
|
)
|
|
|
(69,006
|
)
|
|
|
(67,292
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income
|
|
|
756
|
|
|
|
574
|
|
|
|
3,341
|
|
|
|
2,077
|
|
Interest and bank charges
|
|
|
(52
|
)
|
|
|
(68
|
)
|
|
|
(202
|
)
|
|
|
(133
|
)
|
Accretion expense
|
|
|
(1,183
|
)
|
|
|
(550
|
)
|
|
|
(15,751
|
)
|
|
|
(550
|
)
|
Change in fair value of embedded
derivatives
|
|
|
28
|
|
|
|
|
|
|
|
(870
|
)
|
|
|
|
|
Change in fair value of third party asset-backed commercial paper
|
|
|
(1,184
|
)
|
|
|
|
|
|
|
(1,184
|
)
|
|
|
|
|
Foreign exchange gain (loss)
|
|
|
(54
|
)
|
|
|
245
|
|
|
|
1,130
|
|
|
|
(280
|
)
|
Other income
|
|
|
287
|
|
|
|
282
|
|
|
|
1,274
|
|
|
|
1,348
|
|
Share of loss in a company subject to
significant influence
|
|
|
|
|
|
|
(489
|
)
|
|
|
(327
|
)
|
|
|
(2,440
|
)
|
Non-controlling interest
|
|
|
|
|
|
|
162
|
|
|
|
109
|
|
|
|
801
|
|
|
Net loss
|
|
|
($16,097
|
)
|
|
|
($17,011
|
)
|
|
|
($81,486
|
)
|
|
|
($66,469
|
)
|
|
Net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted
|
|
|
($0.33
|
)
|
|
|
($0.44
|
)
|
|
|
($1.85
|
)
|
|
|
($1.72
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common
shares outstanding
|
|
|
48,896,595
|
|
|
|
38,845,937
|
|
|
|
44,030,474
|
|
|
|
38,654,063
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At
|
|
At
|
|
|
December 31
|
|
December 31
|
Consolidated Balance Sheets
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and marketable securities
|
|
$
|
58,672
|
|
|
$
|
48,758
|
|
Other current assets
|
|
|
3,933
|
|
|
|
10,460
|
|
|
Total current assets
|
|
|
62,605
|
|
|
|
59,218
|
|
Capital assets and patents
|
|
|
9,996
|
|
|
|
8,992
|
|
Other long-term assets
|
|
|
5,830
|
|
|
|
3,192
|
|
|
Total assets
|
|
$
|
78,431
|
|
|
$
|
71,402
|
|
|
|
|
|
|
|
|
|
|
|
Current liabilities
|
|
$
|
21,240
|
|
|
$
|
22,377
|
|
Long-term liabilities
|
|
|
52,602
|
|
|
|
50,017
|
|
Non-controlling interest
|
|
|
680
|
|
|
|
725
|
|
Shareholders equity
|
|
|
3,909
|
|
|
|
(1,717
|
)
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and shareholders equity
|
|
$
|
78,431
|
|
|
$
|
71,402
|
|
|
|
|
|
1
|
|
Condensed from the Companys unaudited quarterly consolidated financial statements and
audited consolidated financial statements available on SEDAR and EDGAR.
|
11
About Neurochem
Neurochem Inc. is a global health company focused on the research, development and
commercialization of products to provide innovative health solutions to address critical unmet
medical needs.
To Contact Neurochem
For additional information on Neurochem and its drug development programs, please call the North
American toll-free number 1-877-680-4500 or visit our Web Site at:
www.neurochem.com.
Certain statements contained in this news release, other than statements of fact that are
independently verifiable at the date hereof, may constitute forward-looking statements. Such
statements, based as they are on the current expectations of management, inherently involve
numerous risks and uncertainties, known and unknown, many of which are beyond Neurochem Inc.s
control. Such risks include but are not limited to: the impact of general economic conditions,
general conditions in the pharmaceutical and/or nutraceutical industry, changes in the regulatory
environment in the jurisdictions in which the Neurochem group does business, stock market
volatility, fluctuations in costs, and changes to the competitive environment due to consolidation,
that actual results may vary once the final and quality-controlled verification of data and
analyses has been completed, as well as other risks disclosed in public filings of Neurochem Inc.
Consequently, actual future results may differ materially from the anticipated results expressed in
the forward-looking statements. The reader should not place undue reliance, if any, on any
forward-looking statements included in this news release. These statements speak only as of the
date made and Neurochem Inc. is under no obligation and disavows any intention to update or revise
such statements as a result of any event, circumstances or otherwise, unless required by applicable
legislation or regulation. Please see the Annual Information Form of Neurochem Inc. for further
risk factors that might affect the Neurochem group and its business.
12
TABLE OF CONTENTS
FORM 51-102F3
MATERIAL CHANGE REPORT
Item 1
Name and Address of Company
|
|
Neurochem Inc. (Neurochem or the Company)
275 Armand-Frappier Blvd.
Laval, Québec
H7V 4A7
|
Item 2
Date of Material Change
Item 3
News Release
|
|
A press release was disseminated by CNW Telbec on February 20, 2008 from Laval, Québec.
|
Item 4
Summary of Material Change
|
|
Neurochem announced the following developments:
|
|
|
|
the name-change from Neurochem to BELLUS HEALTH, pending shareholder approval at the
next annual and special meeting;
|
|
|
|
approval by Neurochems Board of Directors for the creation of subsidiaries for the
purposes of carrying on the Companys nutraceutical business, and as part of these new
developments, the nutraceutical business will be named OVOS NATURAL HEALTH;
|
|
|
|
an amendment under the Equity Line of Credit (ELOC) facility.
|
Item 5
Full Description of Material Change
|
|
5.1
Full Description of Material Change
|
|
|
On February 20, 2008, Neurochem announced that in order to more accurately reflect the
Companys expanded business strategy and core programs that encompass both therapeutics and
branded nutraceutical products, and following
|
|
|
the approval by Neurochems Board of
Directors, the name of the Company will change from Neurochem to BELLUS HEALTH, pending
shareholder approval at the next annual and special meeting.
|
|
|
It was also announced that Neurochems Board of Directors had approved the creation of
subsidiaries for the purposes of carrying on the Companys nutraceutical business, and as
part of these new developments, the nutraceutical business will be named OVOS NATURAL
HEALTH.
|
|
|
|
The Company also announced that it had entered into an amendment with respect to the ELOC
facility. The term of the ELOC facility has been extended to February 2010. The minimum
draw-down obligation by the Company has been reduced to $15,000,000 over the term. The
maximum amount of each monthly draw-down is limited to the lower of $6,000,000 or 12.5% of
the volume-weighted price calculation of the common shares at the time of draw-down. The
common shares will be issued at a discount of 4.0% to market price if the volume-weighted
average price (VWAP) per share is $6 or higher, and 7% if the VWAP per share is lower than
$6 at the time of draw-down.
|
|
|
|
5.2
Disclosure for Restructuring Transactions
|
|
|
|
N/A
|
Item 6
Reliance on subsection 7.1(2) or (3) of National Instrument 51-102
|
|
This report is not being filed on a confidential basis.
|
Item 7
Omitted Information
Item 8
Executive Officer
|
|
Dr. Lise Hébert
Vice-President, Corporate Communications
450.680.4572
|
Item 9
Date of Report
EQUITY LINE OF CREDIT
AMENDMENT NO. 2 TO THE
SECURITIES PURCHASE AGREEMENT
This Amendment No. 2 (Amendment No. 2) by and between Neurochem Inc., a Canadian corporation
(the
Company
) and Cityplatz Limited, a British Virgin Islands corporation (the
Purchaser
) to the August 9, 2006, Securities Purchase Agreement, as previously amended by
Amendment No. 1 in the form of the February 16, 2007, Letter Agreement (collectively, the
Agreement) between the parties, is dated as of February 20, 2008 (the Effective Date of
Amendment No. 2). Capitalized terms used in this Amendment No. 2 and not otherwise defined herein
shall have the meanings ascribed to them in the Agreement.
WHEREAS
, the parties entered into the Agreement pursuant to which the Company has the right to
issue and sell to Purchaser from time to time as provided therein, and Purchaser is obligated to
purchase from the Company up to US$60,000,000 worth of shares of Common Stock on, in the United
States, a private placement basis pursuant to an exemption from registration under Section 4(2) of
the Security Act of 1933;
WHEREAS
, the Purchaser is entitled to resell shares of Common Stock acquired under the
Agreement pursuant to a resale registration statement filed by the Company pursuant to the terms of
the Registration Rights Agreement between the Company and the Purchaser which has previously been
declared effective by the Commission prior; and
WHEREAS
, the parties now wish to further amend certain terms of the Agreement to account for
changes in circumstances and the underlying economics of the transaction as originally contemplated
by the parties at the time the Agreement was executed and the registration statement filed;
NOW, THEREFORE
, in consideration of the foregoing premises, and the promises and covenants
herein contained, the receipt and sufficiency of which are hereby acknowledged by the parties
hereto, the parties, intending to be legally bound, hereby agree that the Agreement be amended as
follows with effect from the Effective Date of Amendment No. 2:
|
1.
|
|
The definition of
Commitment Period
set forth in Section 1.1 of Article I
(Definitions) of the Agreement is deleted and replaced in its entirety by the following:
|
|
|
Commitment Period
shall mean the period commencing on the Effective Date of
Amendment No. 2 and ending at 23:59:59 hrs. on Friday, February 26, 2010.
|
|
2.
|
|
The definition of
Purchase Price
set forth in Section 1.1 of Article I
(Definitions) of the Agreement is deleted and replaced in its entirety by the following:
|
|
|
Purchase Price
shall mean, with respect to Draw Down Shares purchased during
each applicable Settlement Period within a Draw Down Pricing Period:
|
|
a.
|
|
Where the VWAP of the applicable Settlement Period is less than
US$6.000, then 93% of the VWAP of the Settlement Period in question; or
|
|
b.
|
|
Where the VWAP of the applicable Settlement Period is greater than or
equal to US$6.000, then 96% of the VWAP of the Settlement Period in question.
|
|
3.
|
|
The last sentence of Section 6.1(a) of Article VI (Draw Down Terms) of the Agreement is
deleted in its entirely and replaced with the following, the effect of which is to change
the minimum amount to be drawn down by the Company during the Commitment Period (as
redefined above) from US$25,000,000 to US$15,000,000:
|
|
|
6.1(a) ...The Company agrees to request Draw Downs of at least an aggregate
US$15,000,000 during the Commitment Period (as redefined above), subject to Sections
4.8, 6.1(c), 6.1(d) and to the termination of this Agreement, including, without
limitation, pursuant to Article VII hereof.
|
|
4.
|
|
Section 6.1(c) of Article VI (Draw Down Terms) of the Agreement is deleted and replaced
in its entirety by the following:
|
|
|
6.1(c) The maximum Investment Amount as to each Draw Down shall be equal to the lower of
i) US$6,000,000, and ii) 12.5% of the average daily combined volume of the Common Stock
on both the Nasdaq Stock Market and the Toronto Stock Exchange for the 5 Trading Days
immediately prior to the delivery of a Draw Down Notice (delivered under Section 6.1(e)
of the Agreement), multiplied by the VWAP for the same 5 day period, multiplied by the
number of Trading Days within the Draw Down Pricing Period.
|
|
|
The following example is provided purely for the sake of illustrating the calculation of the
maximum Investment Amount and is based upon the following hypothetical information:
|
|
|
|
|
|
|
5 Trading Day Volume:
|
NASDAQ
|
=
|
1,443,187 shares
|
|
|
TSX
|
=
|
808,314 shares
|
|
|
Total
|
=
|
2,251,501 shares
|
|
|
|
|
|
|
|
|
|
|
|
|
Average daily volume: 2,251,501shares ÷ 5 days
|
=
|
450,300 shares traded/day
|
|
|
Number of Trading Days in the Draw Down Period
: 21 days
|
|
|
Calculating the maximum Investment Amount:
|
|
|
|
|
|
12.5% x (450,300 shares/day) x (US$2.3000/share) x (21 days)
|
|
=
|
(56,287.5 shares/day) x (US$2.3000/share) x (21 days)
|
|
=
|
US$129,461.25 per day x 21 days
|
|
=
|
US$2,718,686.20
|
2
|
5.
|
|
Section 7.2(b) of Article VII (Termination) of the Agreement is deleted in its entirety
and replaced with the following, to reflect the parties agreement that the minimum amount
to be drawn down by the Company during the Commitment Period (as redefined above) is
changed from US$25,000,000 to US$15,000,000 (as provided for in Section 3, above, of this
Amendment No. 2):
|
|
|
7.2(b) The Company may terminate this Agreement upon 5 Trading Days notice if: (i) the
Purchaser shall fail to fund a properly noticed Draw Down within 5 Trading Days of the
end of the applicable Settlement Period or (ii) the Company has drawn down at least
US$15,000,000 under this Agreement.
|
|
6.
|
|
Section 7.2(c) of Article VII (Termination) of the Agreement is deleted in its
entirety. There is no longer a right on the part of either party to terminate the
Agreement upon 5 Trading Days notice if the VWAP is below US$5.00 for more than 30
consecutive Trading Days (adjusted for any stock splits and the like after the date of this
Agreement).
|
The parties further agree that, except as amended by this Amendment No. 2, the Agreement remains in
full force and effect and that this Amendment No. 2 supersedes all prior agreements and
understandings, oral or written, with respect to all matters to be amended under the Agreement as
of the Effective Date of Amendment No. 2.
IN WITNESS WHEREOF
, the parties hereto have caused this Amendment No. 2 to be duly executed by
their respective authorized signatories as of the Effective Date of Amendment No. 2.
|
|
|
|
|
Neurochem Inc.
|
|
Cityplatz Limited
|
|
By:
|
(signed) Mariano Rodriguez
Mariano Rodriguez
Vice President, Finance and CFO
|
|
By:
|
(signed) Gordon Mundy
Gordon Mundy
Director
|
|
By:
|
(signed) David Skinner
David Skinner
Vice President, General Counsel
and Corporate Secretary
|
|
By:
|
(signed) Heather Kent
Heather Kent
For and on behalf of Trident Trust
Company (I.O.M.) Limited
Secretary
|
3
Neurochem (NASDAQ:NRMX)
Historical Stock Chart
Von Feb 2025 bis Mär 2025
Neurochem (NASDAQ:NRMX)
Historical Stock Chart
Von Mär 2024 bis Mär 2025